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U.S. Department of Health and Human Services

Class 2 Device Recall Biofinity XR toric

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 Class 2 Device Recall Biofinity XR toricsee related information
Date Initiated by FirmJune 16, 2025
Date PostedJuly 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2165-2025
Recall Event ID 97173
PMA NumberP080011 
Product Classification Lenses, soft contact, extended wear - Product Code LPM
ProductBiofinity XR Toric Contact Lens
Code Information Carton Lot Numbers: RD0226792, RD0227007, RD0227022, RD0227030, RD0227032, RD0228123, RD0228336, RD0228465, RD0228570, RD0228595, RD0228598, RD0228603, RD0228606, RD0228607, RD0228775, RD0228778, RD0228788, RD0228795, RD0228798, RD0228799, RD0228802, RD0228809, RD0228814, RD0228825, RD0228835, RD0228840, RD0228842, RD0228847, RD0228853, RD0228854, RD0228855, RD0228866, RD0228875, RD0228876, RD0228940, RE0152731, RE0152735, RE0152737, RE0152740, RE0152743, RE0152744, RE0152755, RE0152760, RE0152775, RE0152799, RE0152838, RE0152871, RE0152873, RE0152877, RE0152883, RE0152889, RE0152891, RE0152913, RE0152915, RE0152917, RE0153804, RE0153819, RE0153924, RE0153974, RE0154076, RE0154085, RE0154095, RE0154100, RE0154103, RE0154105, RE0154107, RE0154113, RE0154114, RE0154117, RE0154137, RE0154139, RE0154143, RE0154253, RE0154256, RE0154259, RE0154264, RE0154271, RE0154329.
FEI Number 1314956
Recalling Firm/
Manufacturer		 CooperVision, Inc.
711 North Rd
Scottsville NY 14546-1238
For Additional Information ContactAnnette Nelson
925-6604471
Manufacturer Reason
for Recall		Lens blisters may have an incomplete or leaking seal which may render them unsterile.
FDA Determined
Cause 2		Use error
ActionAn URGENT MEDICAL DEVICE CORRECTION notice dated 6/27/25 was mailed to distributors, retailers, and physicians notifying them of this recall. The notification instructs consignees to inspect their inventory for affected devices and stop any further distribution/sale of affected devices. Practitioners are instructed to share the provided Consumer Communication Letter with any patients who received affected devices and to have patients return any units in their possession for replacement or credit. Consignees are to dispose of any affected product in their inventory or that is returned. Consignees are to complete and return the provided Correction Response Form via fax to 888-385-3217 or by email at info@coopervision.com. Consignees with any complaints can contact the Customer Care Team at 855-526-6737; questions about this recall action can be directed to Customer Service at 800-341-2020.
Quantity in Commerce397 units
DistributionWorldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = LPM
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